Medical-Grade PCBs: From Concept to Compliance
Delivering the highest reliability medical electronics with strict adherence to IEC 60601, ISO 13485, and IPC Class 3 standards. Your trusted partner for critical healthcare applications.
What "Medical-Grade" Means (In Practice)
Medical devices demand the highest reliability. Failures can harm patients and trigger recalls. That's why medical electronics follow stricter rules than consumer hardware.
IEC 60601 Compliance
Safety & essential performance standards for medical electrical equipment, addressing leakage currents, insulation, creepage/clearance, and critical alarms.
ISO 13485 & 14971
Quality management systems and comprehensive risk management across the complete product lifecycle for medical devices.
IPC Class 3 Workmanship
Highest reliability build standards with tightened plating thickness, annular rings, and solder joint acceptability criteria.
Biocompatible Materials
Specialized materials and finishes compatible with sterilization processes and biocompatible protective coatings like parylene.
Typical Medical Design Implications
Conservative Design
Enhanced creepage/clearance, robust power delivery networks, and redundant sensing for critical paths.
Sterilization Ready
Materials and finishes compatible with EtO, gamma, and autoclave sterilization processes.
Flexible Solutions
Rigid-flex designs for wearables and catheters to minimize space and survive repeated flexing.
Advanced Protection Solutions
Comprehensive coating and potting solutions designed specifically for medical device requirements and sterilization processes.
Conformal Coating
Advanced protective barriers against moisture, salts, and bodily fluids
Key Features:
- Parylene C coating - biocompatible and sterilization-tolerant
- Thin, pinhole-free protection layer
- Compatible with EtO, gamma, and autoclave sterilization
- Superior chemical resistance
Applications:
Potting & Encapsulation
Maximum protection for critical medical electronics
Key Features:
- Enhanced shock and vibration resistance
- Tamper-resistant encapsulation
- Specialized medical-grade compounds
- X-ray and ultrasound void inspection
Applications:
Precision Manufacturing for Critical Applications
Our medical PCB assemblies undergo rigorous quality control processes, ensuring every component meets the highest standards for patient safety and device reliability.
Flexible Solutions for Complex Medical Devices
Rigid-flex technology enables the creation of small, robust, cable-free assemblies perfect for wearables, surgical tools, and imaging probes.
What MorePCB Can Deliver For Medical Projects
Comprehensive capabilities designed specifically for medical device requirements, from concept development through compliance validation.
Turnkey Fabrication + Assembly
Complete manufacturing solution from concept to delivery
- Manufacturing & component sourcing
- IC programming services
- Functional testing protocols
- EVT/DVT/PVT cycle support
DFM/DFT Guidance
Design for Manufacturing and Testing optimization
- Early design reviews
- IPC standard compliance
- Process limit validation
- Class-3 build de-risking
Material & Stack-up Expertise
Advanced material selection and stack-up design
- FR-4 high-Tg selection
- Polyimide for flex applications
- Controlled-impedance design
- Sensor front-end optimization
Prototype to Scale
Seamless transition from prototype to volume production
- Quick-turn prototypes
- Volume production ramp
- Repeatable process controls
- Supply chain management
State-of-the-Art Testing Facilities
Our advanced testing and inspection facilities ensure every medical PCB meets the stringent requirements for patient safety and regulatory compliance.
Engineering Checklist
Comprehensive checklist for medical PCB design and manufacturing specifications
Standards Compliance
- Target IEC 60601-1 implementation
- Applicable 60601-2-XX standards
- ISO 14971 hazard management
- IPC Class 3 workmanship targets
Stack-up Design
- Controlled impedance requirements
- Copper weight specifications
- Dielectric material notes
- Cleanroom level requirements
Coating & Protection
- Parylene C biocompatible coating
- Sterilization-resistant finishes
- Thickness & mask specifications
- Environmental protection levels
Traceability & Testing
- Lot/date tracking systems
- Material certification records
- Solder paste lot control
- Inspection documentation (AOI/X-ray)
Ready to Start Your Medical PCB Project?
Need help mapping your design inputs to IEC 60601 compliance testing? MorePCB partners with you on manufacturability and documentation so your test lab spends time validating—not finding build issues.
Comprehensive Medical PCB Services
From prototype development to volume production, we provide complete PCB fabrication and assembly services specifically designed for medical device applications.
Prototype PCB Fabrication
Quick-turn prototypes for medical device development
- 24-48 hour turnaround
- Class 3 quality
- Medical materials
FR4 PCB Fabrication
High-Tg FR4 materials for medical applications
- High-temperature tolerance
- Enhanced reliability
- Biocompatible options
PTFE RF PCB
RF/microwave PCBs for medical imaging
- Low loss tangent
- Stable dielectric
- Precision controlled
Rigid-Flex PCB
Flexible solutions for wearable medical devices
- Space-saving design
- Enhanced durability
- Cable-free connections
HDI PCB
High-density interconnect for compact medical devices
- Miniaturized design
- Enhanced performance
- Complex routing
Ceramic PCB
Superior thermal management for medical electronics
- Excellent heat dissipation
- Chemical resistance
- High reliability
Medical Device Specialty Services
Additional services specifically designed for medical device manufacturing
Our Medical PCB Process
Streamlined workflow from concept to compliance
1. Design Review
DFM analysis and compliance assessment
2. Manufacturing
Class 3 fabrication and assembly
3. Testing
Comprehensive testing and inspection
4. Documentation
Complete traceability and compliance docs
Start Your Medical PCB Project Today
Contact our medical PCB specialists to discuss your project requirements and learn how we can help you achieve compliance and quality goals.
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